CLASS II ONGOING Device recall · Reported 3 Sep 2025 · FDA Enforcement Report
Orascoptic Superior Visualization Phantom Essential kit recalled
Orascoptic Surgical Acuity is recalling Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens, distributed nationwide in the US. The recall was initiated on 3 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2443-2025
- FDA event ID
- 97260
- Recalling firm
- Orascoptic Surgical Acuity, Orange, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Jul 2025
- FDA classified
- 26 Aug 2025
- Reported
- 3 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Jul 2025 | Recall initiated by company | |
| 26 Aug 2025 | Classified by FDA | +54 days |
| 3 Sep 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Product as listed by the FDA
Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Where it was distributed
Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Which lots are affected?
All kits manufactured between June 6, 2023 - May 14, 2025
Where was it sold?
Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 97260This product is part of a recall event; the main page for the event is Orascoptic Superior Visualization Dragonfly Essentials Kit recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Orascoptic Superior Visualization Dragonfly Essentials Kit recalled | Orascoptic Surgical Acuity | Other | Nationwide | |
| CLASS II | Orascoptic Superior Visualization Phantom Nose Pad recalled | Orascoptic Surgical Acuity | Other | Nationwide | |
| CLASS II | Orascoptic Superior Visualization Dragonfly Nose Pad recalled | Orascoptic Surgical Acuity | Other | Nationwide | |
| CLASS II | Orascoptic Superior Visualization Custom loupes recalled | Orascoptic Surgical Acuity | Other | Nationwide | |
| CLASS II | Orascoptic Superior Visualization Custom loupes configured recalled | Orascoptic Surgical Acuity | Other | Nationwide |
More recalls from Orascoptic Surgical Acuity
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Orascoptic Superior Visualization Custom loupes configured recalled | Orascoptic Surgical Acuity | Other | Nationwide |
| Device | CLASS II | Orascoptic Superior Visualization Custom loupes recalled | Orascoptic Surgical Acuity | Other | Nationwide |
| Device | CLASS II | Orascoptic Superior Visualization Dragonfly Nose Pad recalled | Orascoptic Surgical Acuity | Other | Nationwide |
| Device | CLASS II | Orascoptic Superior Visualization Phantom Nose Pad recalled | Orascoptic Surgical Acuity | Other | Nationwide |
| Device | CLASS II | Orascoptic Superior Visualization Dragonfly Essentials Kit recalled | Orascoptic Surgical Acuity | Other | Nationwide |
Other Other Medical Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |